Several questions are asked about light curing adhesives and are answered by Irene Boutin, Application Engineering Manager, Dymax Corporation
Several questions are asked about light curing adhesives and are answered by Irene Boutin, Application Engineering Manager, Dymax Corporation
Well (deep subject, the doctor knows), I know many of the readers were wondering about Dr. D’s next series. The doctor really wanted to make this next series an enjoyable surprise. That being said, surprise, surprise, surprise (thank you Gomer Pyle USMC); the next series of Dr. D’s articles will be focused on complying with MHLW Ministerial Ordinance Number 169.
Compliant, noncompliant and semi-compliant balloons—which one is right for you? Read to know how to choose the right manufacturing process for your silicone medical balloon.
Compliant, noncompliant and semi-compliant balloons—which one is right for you? Read to know how to choose the right manufacturing process for your silicone medical balloon.
During the course of the last eight months, Dr. D has had the opportunity to dive into 98/79/EC, the European In-Vitro Diagnostic Medical Device Directive while extracting salient elements in the hope of providing Devine Guidance for the readers. This journey has now come to an end.
Life adapts and evolves. Biomimcry is nested within that statement and can take you wherever you wish to go. The question is, how far do YOU want to take it?
Dr. D has just one takeaway from this edition of DG; “Just comply baby!” It does not get any easier than that, well maybe not that easy.
The relationship between the notified body and the device manufacturer is not unlike a marriage. If a positive relationship is garnered and sustained, life is beautiful. If the relationship sours, then divorce is inevitable; and then the phrase is; “I want my CE mark back, now!”
The relationship between the notified body and the device manufacturer is not unlike a marriage. If a positive relationship is garnered and sustained, life is beautiful. If the relationship sours, then divorce is inevitable; and then the phrase is; “I want my CE mark back, now!”
Software verification and validation is a process that produces objective evidence that the software in a medical device has been thoroughly designed, tested, and meets user requirements. The level of depth of testing and documentation is based on overall risk. This installment of ‘ Ask the Engineer ’ addresses the question of when and where to start the software verification and validation process.
This week’s guidance for IVDD Annex VII reiterates a device manufacturer’s commitment to supplying a device capable of providing accurate and repeatable results and ongoing compliance with the Directive.
This week’s guidance for IVDD Annex VII reiterates a device manufacturer’s commitment to supplying a device capable of providing accurate and repeatable results and ongoing compliance with the Directive.
When it comes to understanding which colors to choose, how to apply color and why, and what kinds of materials and surface finish create the most value, design expertise and direction is required. It’s time to make medical products object of desire rather than disinclination.
